Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)
NCT ID: NCT04676997
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-05-20
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Camrelizumab+Chemotherapy
Participants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery
Camrelizumab
200mg on days1,15 of Cycles 1-4 (Q2W); IV infusion. 200mg on day 1 of Cycles 5-8 (Q2W); IV infusion.
Nab paclitaxel
125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.
Epirubicin
90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
Cyclophosphamide
600 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
Interventions
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Camrelizumab
200mg on days1,15 of Cycles 1-4 (Q2W); IV infusion. 200mg on day 1 of Cycles 5-8 (Q2W); IV infusion.
Nab paclitaxel
125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.
Epirubicin
90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
Cyclophosphamide
600 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
Eligibility Criteria
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Inclusion Criteria
2. 18-70 Years, female;
3. life expectancy is not less than 3 months
4. Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status);
5. Stage at presentation: T1c N1-2 or T2-4 N0-2;
6. at least one measurable lesion according to RECIST 1.1;
7. Adequate function of major organs meets the following requirements:
* Neutrophils ≥ 1.5×10\^9/L
* Platelets ≥ 100×10\^9/L
* Hemoglobin ≥ 90g/L
* lymphocyte≥0.5×10\^9/L
* Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
* ALT and AST ≤ 3 × ULN
* ALP≤ 2.5 × ULN
* BUN and Cr ≤ 1.5 × ULN
* TSH≤ ULN
* Left ventricular ejection fraction (LVEF) ≥ 50%
* QTcF ≤ 470 ms
8. Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1);
9. For women of childbearing potential: agreement to use contraceptive methods. Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 72 hours prior to initiation of study drug.
Exclusion Criteria
2. Inflammatory breast cancer
3. patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
4. Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
5. Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
6. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
7. Major surgical procedure within 4 weeks prior to initiation of study treatment
8. Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
9. Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases
10. Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study
11. Has a known history of Human Immunodeficiency Virus (HIV).
12. Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis
13. Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
14. Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment
15. Has evidence of active tuberculosis within 1year prior to initiation of study treatment
16. Prior allogeneic stem cell or solid organ transplantation
17. Pre-existing motor or sensory neuropathy of a severity≥grade 2
18. Has significant cardiovascular disease
19. Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
20. Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
21. Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
22. Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
23. History of neurological or psychiatric disorders, including epilepsy or dementia.
24. any other situation evaluated by researchers
18 Years
70 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Jinming Yu
Director of Shandong Cancer Hospital and Institute
Locations
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Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Jinming Yu, MD
Role: primary
Yongsheng Wang, MD
Role: backup
Other Identifiers
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MA-BC-II-006
Identifier Type: -
Identifier Source: org_study_id